1. Conducting and Reporting QA audits
Literature survey
Ashish Kumar Awadhiya
Quality Assurance and Training
2. Table of Contents
Definitions
Role of QA personals
Guidelines for conducting and reporting QA
audits
References
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3. Definition
•Good Clinical Practice • that provides assurance
(GCP)
• that the data and reported
•A standard for results are
•design, conduct, • credible and accurate
•performance, monitoring, • and that the rights, integrity
•auditing, recording, and confidentiality of trial
subjects are protected.
•analyses and reporting of
clinical trials
[1.24, ICH – GCP, E6]
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4. Definition
•Quality Assurance (QA):
All those
planned and systematic actions
that are established to ensure that
the trial is performed and
the data are generated, documented (recorded), and
reported in compliance with
GCP and the applicable regulatory requirement (s).
[1.46, ICH-GCP, E6]
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5. Definition
• Audit :
A systematic and independent examination of trial
related activities and documents to determine whether
the evaluated trial-related activities were
conducted ,
and the data were recorded ,
analyzed and accurately reported ,
according to the protocol, sponsor’s SOP, GCP and
the applicable regulatory requirement (s).
[1. 6, ICH- GCP E6]
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6. Role of QA
Preparation and review of SOPs
To act as a moderator for quality improvement
To provide advice on GCP matters
To train the clinical research staff
To confirm GCP and applicable regulatory compliance
To plan and conduct audits
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8. Purpose
To define the procedures and operations for conducting
and reporting the Quality Assurance Audits
Includes procedures and activities about conduct and
report the audits
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9. Responsibilities
Quality Assurance Unit / Auditor
Plans, communicates and conducts the audits
Propose corrective action plan if applicable
Project / Clinical Team
Ensures that documents and resources required to
perform audits are provided.
Ensures that corrective / preventive actions are taken
place and gives written communication for the same
(Audit Response)
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10. Procedures
Project selection
Audit Plan
Back ground information to prepare audit tools
Audit plan preparation (audit objectives, scope of
assessment, methodology, time frames)
Review of audit plan with Project head and finally
sign off by QA Head.
Intimation of audits to all concerned persons
Filing of audit plan
If amended, should be intimated the same
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11. Procedures
Conducting Audits
Shall be conducted as per audit plan and applicable
SOPs
Should include opening interview with key personals to
clear the objectives of the audit, current procedures,
review of relevant documents.
Should end with closing interview to discuss the
observation and mutual agreement on the same
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12. Procedures
Reporting Audit Findings
Should be based on defined grading : Minor, Major
and Critical
Special attention to Major and Critical findings: time
frame and level of intimation.
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13. Procedures
Reporting Audit Findings
Should be clear, consistent and appropriate
Should be accurately arranged according to severity.
Should be approved by Head QA or designee
Should be distributed within time frame to respective
persons with confidentiality
Significant misconduct and fraud should be
reported separately up to the Higher Management
Post compliance audit can be planned in necessary
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14. Procedures
Responding to Audits
Should be within time frame
Should have corrective action plan
If possible provide the proof for the action planned
and executed
Written confirmation is necessary for critical/major
findings
Should resolve all the queries to close the audit
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15. Procedures
Audit Closure
Should be after receiving the satisfactory responses
Auditor will enter the same in QA audit log
Audit Certificate should be issued by the Auditor
[5.19.3, ICH-GCP,E6]
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